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E-Type - Early Wear of Polyethylene Liners Used in DMC
Sponsor: Uppsala University
Summary
This is a single-centre, randomized, double-blinded controlled non-inferiority trial that will be conducted at the Orthopaedic Department at Uppsala University Hospital, Uppsala. The aim of the study is to evaluate the performance of a dual mobility acetabular component with a Vitamin E-infused highly crosslinked polyethylene (VEPE) liner compared to a conventional polyethylene (PE) liner in adult patients with symptomatic osteoarthritis, osteonecrosis, or dysplasia of the hip requiring a hip replacement. The assessments will focus on early wear, cup migration, adverse events, and clinical outcomes. Measurements will be conducted using Computed Tomography Radiostereometric Analysis (CT-RSA) instead of traditional radiostereometric analysis. The study hypothesis is that the PE liner will be non-inferior to the VEPE liner in terms of early wear over a two-year period.
Official title: Early Wear Patterns Detected With CT RSA in Vitamin E-infused Liner Versus Conventional Highly Crosslinked Liner After Total Hip Arthroplasty With Dual Mobility Cups: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-10-02
Completion Date
2033-10-01
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Total Hip Arthroplasty
All patients will be operated with an anterolateral or posterior approach using a cemented or uncemented cup (BiMobile, Waldemar Link GmbH, Hamburg, Germany).
Locations (1)
Uppsala University Hospital
Uppsala, Uppsala County, Sweden